The Role of Natural Orifice Specimen Extraction Surgery (NOSES) in Treating Right-sided Colon Cancer

NCT06753968 | Completed

• 1 other identifier: NOSES for right hemicolectomy
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the short-term and long-term outcomes between natural orifice specimen extraction surgery (NOSES) and totally laparoscopic right hemicolectomy (TLRH). The hypothesis is that NOSES could achieve good short-term and oncological outcomes for right colon cancer patients.

Conditions

Colon Cancer

Keywords

colon cancer; totallly laparoscopic right hemicolectomy; natural orifice specimen extraction surgery

Outcome Measures

Primary Outcomes (1)

• The rate of postoperative complications

  The rate of postoperative complications = patients with any postoperative complications/all cases.

  up to 30 days

Secondary Outcomes (3)

• Operating time

  up to 1 days

• The time of first flatus

  up to 5 days

• Postoperative hospitalization

  up to 30 days

Other Outcomes (1)

• Estimated blood loss

  up to 1 days

Study Arms (2)

Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES)

EXPERIMENTAL

The NOSES group employs two distinct methods for specimen extraction, both of which have been thoroughly outlined in previous studies. The first method, transvaginal extraction, begins with the irrigation and disinfection of the vagina, followed by a transverse incision in the posterior fornix. The assistant then utilizes oval forceps to carefully extract the specimen bag through the incision, which is subsequently closed with continuous full-thickness sutures, using barbed sutures to ensure secure closure. The second method, transrectal extraction, similarly begins with irrigation of the rectum using a dilute iodine solution, followed by a longitudinal incision along the anterior wall of the upper rectum. The specimen, along with the protective sleeve, is then removed using oval forceps, and the incision is closed with a continuous full-layer running suture once the specimen has been completely extracted.

Procedure: Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES)

Totally Laparoscopic Right Hemicolectomy (TLRH)

ACTIVE COMPARATOR

Totally Laparoscopic Right Hemicolectomy (TLRH), which involves performing intracorporeal anastomosis and specimen extraction through a small abdominal incision, enhances the benefits of minimally invasive surgery In the TLRH group, following the stapled side-to-side anastomosis, a small horizontal incision is made about 2 to 3 cm above the symphysis pubis, at the junction of the pubic hairline, to allow for specimen removal.

Procedure: Totally laparoscopic right hemicolectomy (TLRH)

Interventions

Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES) PROCEDURE

Transvaginal extraction, begins with the irrigation and disinfection of the vagina, followed by a transverse incision in the posterior fornix. The assistant then utilizes oval forceps to carefully extract the specimen bag through the incision, which is subsequently closed with continuous full-thickness sutures, using barbed sutures to ensure secure closure. Similarly, transrectal extraction begins with irrigation of the rectum using a dilute iodine solution, followed by a longitudinal incision along the anterior wall of the upper rectum. The specimen, along with the protective sleeve, is then removed using oval forceps, and the incision is closed with a continuous full-layer running suture once the specimen has been completely extracted.

Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES)

Totally laparoscopic right hemicolectomy (TLRH) PROCEDURE

Totally laparoscopic right hemicolectomy (TLRH), which involves performing intracorporeal anastomosis and specimen extraction through a small abdominal incision, further enhances the benefits of minimally invasive surgery. In the TLRH group, following the stapled side-to-side anastomosis, a small horizontal incision is made about 2 to 3 cm above the symphysis pubis, at the junction of the pubic hairline, to allow for specimen removal.

Totally Laparoscopic Right Hemicolectomy (TLRH)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven colon carcinoma;
• Imaging diagnosis of T1-3 colon cancer;
• The tumor located in the cecum, ascending colon, or colonic hepatic flexure;
• Written informed consent;

You may not qualify if:

• Complete intestinal obstruction;
• Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
• Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation;
• Pregnancy or breastfeeding;
• Alcohol abuse or drug addiction;
• Concurrent uncontrolled medical condition;

Sponsors & Collaborators

• National Cancer Center, China: lead

Study Sites (1)

National Cancer Center, Beijing, Beijing 100000

Beijing, China

Location

Related Publications (1)

• Li XW, Wang CY, Zhang JJ, Ge Z, Lin XH, Hu JH. Short-term efficacy of transvaginal specimen extraction for right colon cancer based on propensity score matching: A retrospective cohort study. Int J Surg. 2019 Dec;72:102-108. doi: 10.1016/j.ijsu.2019.07.025. Epub 2019 Jul 27.

  PMID: 31362128 RESULT

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Haitao Zhou

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 31, 2024
• Study Start: January 1, 2018
• Primary Completion: January 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)